Abstract: An immunoassay procedure for detection of analytes in urine wherein an immunological reaction is conducted in an aqueous phase containing the urine and a filterable immunocomposite containing an inherently colored gold sol particle is formed if the assay is positive. The colored, gold sol particle containing immunocomposite is collected for direct visual observation on a filter element.

Abstract: An assay procedure for predicting the onset of the ovulation in a human subject. Urine samples are obtained on consecutive days and assayed for total gonadotropal alpha peptide chain content. The alpha chain content surges to indicate ovulation and the onset of the fertile period.

Abstract: A simultaneous dual analyte assay for determining the fertile period of the human menstrual cycle. The assay utilizes a capture reaction component consisting of P-3-G immobilized on a microporous membrane, a blocking reaction component consisting of anti E.sub.1 -3-G antibody, a labelled reaction component consisting of gold particle labelled anti E.sub.1 -3-G antibody, and an ambifunctional reaction component consisting of a hybrid immunoreactive substance having an anti P-3-G antibody binding site and a plurality of E.sub.1 -3-G determinant binding sites. An aqueous sample containing P-3-G and E.sub.1 -3-G is contacted with the components and the assay is calibrated to provide a positive assay result only when the concentration of P-3-G in the sample is less than a predetermined concentration and the concentration of E.sub.

Abstract: An immunoassay procedure for detection of analytes in urine wherein an immunological reaction is conducted in an aqueous phase containing the urine and a filterable immunocomposite containing an inherently colored gold sol particle is formed if the assay is positive. The colored, gold sol particle containing immunocomposite is collected for direct visual observation on a filter element.

Abstract: An immunoassay method comprising applying an aqueous solution containing the analyte antigen to one end of a multi-zoned test strip device such that the solution moves along the strip by capillary action. The zones are arranged so that the solution (a) first contacts and reconstitutes dry, diffusible labelled component comprising colloidal gold conjugated to an antibody specific for said analyte antigen and then (b) contacts and reconstitutes dry, diffusible biotinylated second antibody specific for said analyte antigen such that a diffusible, dispersed sandwich reaction product forms. The reaction product diffuses along the strip with the solution and into a zone containing capture component consisting of a latex and avidin complex which avidin collects the reaction product by means of reaction with its biotin moiety. Thus, gold particles are collected and concentrated in the detection zone for visual determination.

Abstract: A lyophilized mixture of reactants for an immunoassay includes antibody-gold sol particle conjugates, antibody latex particle conjugates, polyethylene glycol, a polyethylene glycol p-isooctylphenyl ether detergent and a sugar such as dextrin or trehalose. The polyethylene glycol is present to enhance binding of the immunoreactants and the polyethylene glycol p-isooctylphenyl ether detergent is present to prevent non-specific interactions. The sugar prevents agglomeration of the polyethylene glycol and polyethylene glycol p-isooctylphenyl ether in the lyophilized mixture at room temperature and facilitates retention of a homogenous distribution of the ingredients of the mixture to thereby enhance shelf life and redistribution of the mixture in an aqueous test system.

Abstract: A test kit for performing a diagnostic procedure. The kit comprises a plastic base which has an upper surface. The base is formed from a plastic material and a plurality of upwardly opening nests are provided in the upper surface of the base. A test component is provided in each of the nests in a manner such that the components may be displayed and made available for use. The test components are preferably displayed in essentially the plane of the upper surface of the base and an instruction booklet is provided so as to overlie the test components at the beginning of the procedure. The arrangement of the components and the size and shape of the pages of the booklet are such that as the user follows the instructions and turns pages in the booklet, components remain hidden from view until needed in conducting the procedure. The pages of the booklet are progressively shorter from front to back in the booklet so that as the pages are turned components of the kit come into view as needed.

Abstract: A disposable, pre-packaged device as particularly suitable for conducting diagnostic procedures based on immunological reactions using specimens gathered up in the absorbent tip of a swab. The device is made up of a base component upon which a sample sensitive element is mounted and a guide member that is normally mounted on the base component in covering relationship to the reactive element. The guide member includes structure which defines an elongated passageway extending therethrough. One end of the passageway is positioned in close proximity to the sensitive element when the member is mounted on the base component. The other end of the passageway opens outwardly of the guide member. In using the device, the swab tip is pushed through the passageway and toward the sensitive element using the stick of the swab. A number of ribs are positioned in the passageway adjacent the sensitive element to squeeze the tip and express fluid therefrom as the tip is pushed toward the sensitive element.

Abstract: A disposable, pre-packaged device for conducting an immunoassay procedure that results in the production of separable liquid and solid phases. The device includes a cup having an inlet and presenting a liquid phase receiving chamber. An absorbent for liquid phase materials is in the chamber and a series of ribs hold the absorbent away from the walls of the chamber providing a breathing space extending around the absorbent. A porous capture media element for capturing and displaying solid phase products of the procedure is disposed adjacent the inlet of the device in fluid communication with the absorbent so that in operation the absorbent promotes flow of liquid phase through the capture element. A lid element is mounted on the cup adjacent the inlet and the lid and the cup are held together by welding of annular flanges. The lid element includes an elongated cylindrical member extending through the inlet and defining a throat for directing flow of liquid phase onto the capture media.

Abstract: A disposable, pre-packaged device is particularly suitable for conducting diagnostic procedures based on immunological reactions using specimens gathered in the absorbent tip of a swab. The device is made up of an elongated holder member which includes structure for supporting and positioning a swab, another holder member hingedly mounted at one end of the swab holder member and which carries a capture media element assemblage suitable for conducting an immunoassay test. The device also includes a cover member hingedly mounted on the opposite end of the swab holder member. The cover member includes structure positioned for pressing the swab tip against the capture element when the device is operated. Thus, the light in the swab tip is squeezed and the test fluid is expressed therefrom and brought into intimate contact with the capture element. The results of the test are visually observable by simply swinging the member which carries the capture element away from the swab holder member.

Abstract: An assay procedure that is particularly valuable for detecting and/or determining the presence of threshold levels of analyte ligands in biological fluids. In one particularized and specialized aspect the disclosure is directed to procedures for detecting and/or determining threshold levels of hormone metabolites such as pregnanediol-3-glucuronide (P.sub.3 G) and estrone-3-glucuronide (E.sub.1 3G) in human urine. The assay consists of contacting a sample containing the analyte with a known amount of an antibody thereto and with a calibrated amount of the analyte itself that is conjugated to said solid support. When the level of the analyte in the sample exceeds a threshold level, such as 5 ug/ml for P.sub.3 G, the antibody will be insufficient to block all of the corresponding analyte on the solid support.

Abstract: Antibody coated gold sol particles and antibody coated solid phase particles dispersed in an aqueous system react immunologically as a function of the presence of an analyte in a sample to be analyzed to produce a collectible, solid phase, gold-containing composite. The composite is collected on a filter or at the bottom of a test tube by centrifugation or gravitation and the analyte in the sample is determined or detected by direct visual examination of the collected solid phase composite which has a pink or red or purplish coloration as a result of the gold contained thereby. The materials required for conducting the assay comprise coated gold particles, coated solid phase particles and a collector element such as a filter. The collected, solid phase, metal-containing composite, which may be directly visually examined to determine or detect the gold therein and thus the analyte in the sample, is stable and remains available for confirmation of test results at a later time.

Abstract: A vessel containing a polymeric acid is used in a method and test kit for extracting a bacterial (e.g., streptococcal) antigen from a test sample, for example, preliminary to an immunoassay. To extract the antigen from bacteria in the sample, a precursor reagent is applied to the vessel acid and incubated with the sample. The kit includes a vial containing the acid and another vial containing the precursor. The kit is produced by including the acid polymer in the vial or vessel, e.g., as a pellet or coating.